Submission to the Association on the Review of NHMRC Guidelines on the Ethical Conduct of Research Involving Human Subjects

December 1996

Supplementary Note 1: Institutional Ethics Committees

A report was recently produced for the Minister for Health and Family Services on the role and functioning of Institutional Ethics Committees (IECs) (1).

There are a number of issues arising from the structure and functioning of IECs:

Composition

At present an IEC has a minimum membership consisting of:

a lay woman not associated with the institution

a layman not associated with the institution (a lay person is one who is not closely involved in medical, scientific or legal work)

a minister of religion

a lawyer

a medical graduate with research experience. (IECs Report, page 12)_

The NHMRC requires an application for a research grant from the Council to be certified by the Ethics Committee of the applicant’s institution. This requirement applies to both medical and health research projects. The IECs Report found the present minimum membership requirements inadequate to ensure appropriate approval and monitoring of social science research in the health area, pointing to the inappropriate requirement that a medical graduate sit on an IEC concerned with this area of research (IECs Report, pages 44-45).

The Association would go further and question the adequacy of the minimum requirement of a graduate member with research experience (whether that graduate have a medical or social sciences background). Unless this graduate has sound professional knowledge by which to judge the worth of the particular research proposal and the full import of what it might involve for the human, his/her presence on the IEC might be an inadequate safeguard to ensure that the proposed research is ethical in its treatment of human subjects.

The ‘in-house’ nature of the approval and monitoring process must raise serious doubts about its efficacy. It is not unlikely that the ‘research’ person on the IEC, while not actively involved in the project under consideration, might still lack the necessary objectivity in the approval and/or subsequent monitoring process. The ‘specialist’ member of the IEC may be a colleague of the applicant or be of inferior rank (in an employment or scientific status sense) to the applicant. Peer review of scientific work may be a generally sound concept when the reference is to a wider community of scientific colleagues. However, intra-institutional review can be questioned on the grounds of lack of relevant expertise – especially in smaller institutions, and lack of objectivity where colleagues are either favoured or where the IEC member may fear redress in his/her subsequent career in the institution.

The Report pointed to the fact that many IECs themselves feel that they lack the necessary expertise to fulfil their essential role, that is to ensure that the rights of the research subject take precedence over expected benefits to knowledge. Submissions revealed a clear need to streamline the review process and to relieve the IECs of the frequently burdensome task of assessing scientific merit of proposals. The Report’s rejection of a ‘peak’ national body to provide this assistance and of regional IECs for the same purpose is surprising (IECs Report, Recommendation 2). The Report’s recommendation that IECs continue to work to improve communication in relation to multi-centre research protocols is an inadequate response to a problem posed cogently by IECs themselves (IECs Report, Recommendation 3).

Again in the 1995 AHEC Workshops many IECs expressed dissatisfaction with their own monitoring procedures; the procedures were superficial with reliance on written reports of the researcher(s) owing to lack of resources to monitor effectively.

However, the Review Committee surprisingly did not support the establishment of a separate administrative system of monitoring (IECs Report, pages 30-31).

The Report’s assessment that sanctions are not necessary is too sanguine. The Committee comments that approval for a project might be withdrawn by the institution if protocols and/or guidelines were breached; this could be followed by a recommendation by the IEC to an outside sponsor that funds be withdrawn from an errant researcher. This is an unreal expectation and places the IEC in an invidious position vis-a-vis its own institution where loss of resources and staff could be the outcome.

The Association favours the establishment of a national body as advocated by the Family Law Council of Australia (2) and the Report of the Senate Select Committee on the Human Embryo Experimentation Bill 1985 (3). The body would have executive functions to regulate experimentation on human subjects. This body would formulate guidelines, consider research protocols, and monitor research procedures to ensure compliance with guidelines; the body could initiate action by way of prosecution or injunction against a researcher carrying out prohibited or unapproved experimentation. This body should be separate from the NHMRC which has broader functions.

Supplementary Note 2: Research on children, the mentally ill, those in dependent relationships or comparable situations

Children

The Association approves the general thrust of this Note in relation to children who are research subjects: the general statement of principles in relation to the ethics of research, the obtaining of consent, and the minimising of risk to the child.

The mentally ill

The Note recommends that, where consent cannot be obtained from a person owing to his/her mental illness, “consent should also be obtained from the person who stands legally in the position of guardian, next friend, or the like” (NHMRC Statement on Human Experimentation and Supplementary Notes 1992, page 9). This approach arguably provides insufficient protection to the mentally incompetent potential subject of experimentation. It must be admitted that the legal guardian or suchlike of a mentally incompetent might have a pecuniary or other interest in that person’s affairs or be burdened with constant care of the person.

The Association recommends the appointment of a patient advocate in such instances. While the views and wishes of the legal guardian or suchlike should carry considerable weight in the final decision about the incompetent’s participation in the experimentation, objectivity can better be ensured by the appointment of an advocate.

Those in dependent relationships or comparable situation

The NHMRC has rightly drawn attention to the “special attention” required in relation to such persons (including elderly persons, wards, prisoners, those in teacher/student or doctor/patient relationships) being included in experimental protocols. This advice is vague and does not provide sufficient guidance or direction to IECs or to researchers preparing proposals for experimentation.

In order to provide sufficient protection to those persons in dependent relationships and comparable situations, the Association supports the development of more detailed guidelines and clarifications of the obligations which researchers and IECs bear to such persons.

The Association recommends the appointment of a patient advocate in such instances. While the views and wishes of the legal guardian or suchlike should carry considerable weight in the final decision about the incompetent’s participation in the experimentation, objectivity can better be ensured by the appointment of an advocate.

Supplementary Note 5: The human fetus and the use of human fetal tissue

The fetus in utero

The Note poses the likely propriety of research on the human:

where the research is consistent with the promotion of life or health of the fetus; and

where the research is designed to assist antenatal fetal diagnosis and thereby offer to the mother better informed choice about her pregnancy, including the choice of aborting the fetus (NHMRC Statement, page 16, para. 3).

There is an inherent contradiction here in that the outcome of the second type of experimentation might not be in the best interests of the human subject if the outcome is to be destruction of the subject, whether directly or through facilitation of the mother’s decision to reach the same outcome.

While the Note does advert to the possible risks to mother and/or child from such experimentation, the only guidance offered is that IECs “should carefully consider the risks and benefits to both in every case”. (NHMRC Statement, page 16, para. 4). This falls short of the standard urged for experimentation on children in Supplementary Note 2:

The risk to the child should be so minimal as to be little more than the risks run in everyday life. Risks of research in this context include the risk of causing physical disturbance, discomfort, anxiety, pain or psychological disturbance to the child or the parents rather than the risk of serious harm, which would be unacceptable(NHMRC Statement, page 9).

The Association recommends the appointment of an advocate for the protection of the life and/or health of the fetus in such instances. While the views and wishes of the mother and/or father should be taken into account, objectivity can better be ensured by the appointment of an advocate.

Though the Statement precludes any procedure which is likely to harm the fetus destined to be aborted, the inclusion of a fetus so destined in any experimental protocol should not be permitted without the oversight of an independent advocate for the fetus. It is a matter of common sense not to give a decision of this type to a person who has declared her decision not to preserve the life of the fetus; objectivity should not be assumed. It is too sanguine to presume disinterest on the part of experimenters wanting fetal subjects for an allegedly non-harmful experiment; and it is not too difficult to suppose that it is easier to obtain consent from the mother in these circumstances for the participation of the fetus in the project.

The Association again recommends the appointment of an advocate for the protection of the life and/or health of the fetus in such instances. It considers that this course of action is especially pertinent where the mother has indicated her wish to have an abortion.

The separated pre-viable fetus and fetal tissues

The Statement is of the opinion that the fetus should be available for research only as a result of separation by natural process or by lawful means (ie. abortion). For the reasons already stated, the Association wishes to draw attention to the dangers of making tissue available from abortion. The dangers of lack of objectivity and less than scrupulous arrangements for tissue collection must be faced. There will in some instances be an inevitable presumption that tissue garnered from the fetus will be available, especially the provision is part of an established arrangement for an ongoing research project. Objectivity in judgement as to the viability of the fetus could be comprised.

The danger increases as there is expectation of an available supply of fetal tissue for therapeutic application to other human subjects. The supply of fetal tissue for such alleged benefits is particularly fraught with the peril of departing from acceptable standards. It is inevitable that the fetus will be farmed for personal and scientific gain. The present Statement does not adequately address such problems.

End Notes

(1)Report of the review of the role and functioning of Institutional Ethics Committees: A Report to the Minister for Health and Family Services. March 1996.

(2) Family Law Council, (1985) Creating Children: A Uniform Approach to the Law and Practice of Reproductive Technology in Australia. July. AGPS, Canberra.